KNOXVILLE, Tenn., Jan. 10 /PRNewswire-FirstCall/ -- Provectus Pharmaceuticals, Inc. CEO Craig Dees today issued the following open letter to shareholders and interested members of the investment community to update all parties on the Company’s recent operational and clinical progress.
Dear Provectus Pharmaceuticals shareholder:
The entire team at Provectus is quite excited about our recent achievements in the clinical development of Provecta(TM) (PV-10) for treatment of patients with metastatic melanoma and recurrent breast cancer. In contrast to most current cancer treatments, which can have notoriously serious side effects due to limited specificity for diseased tissue, Provecta has the potential to change the paradigm in oncology because its effects are almost exclusively focused on diseased tissue. Our pre-clinical studies support this assertion since a high percentage of animals treated with Provecta were free of tumors upon completion of a single course of therapy. In all cases systemic side effects were negligible or absent.
In 2005, we achieved a significant milestone by advancing Provecta from pre-clinical studies to two clinical trials in humans with metastatic melanoma or breast cancer. At year end, we had ten subjects enrolled in our metastatic melanoma clinical trial in Australia. Nine of the subjects have been treated with Provecta and we expect the tenth to be treated in the near future. We also have one subject who has completed treatment with Provecta in our breast cancer clinical trial in New Zealand, with two more subjects eligible for treatment in January 2006. We anticipate that this initial phase of clinical trials will be completed as projected in early 2006. To date, no subject has suffered any severe systemic or local adverse side effects from Provecta. Effects at the treatment site have been comparable to those observed in pre- clinical animal models, characterized by dramatic, rapid tumor destruction with no significant effects in the surrounding normal tissue.
During 2006 we expect our clinical program to expand to include liver cancer patients at one or two study sites in Australia. We also anticipate that Phase 2/3 clinical trials of Xantryl(TM) for psoriasis and eczema will begin with sites in the US and abroad. We may also begin a small clinical trial to document the effects of our over-the-counter (OTC) acne treatment that could greatly increase its value in licensing negotiations.
We continue to advance the licensing of our OTC products and our other non-core technologies that include biotechnologies and medical devices.
We have also completed an equity-funding round that has raised funds sufficient to support the Company’s efforts well through 2007. We now have funds that will support all our planned clinical trials along with modest increases in clinical efforts like those for the OTC acne product. We have also significantly reduced our debt by converting notes to equity. This has been achieved with a modest increase in stock price and trading volume.
The team at Provectus looks forward to continuing our efforts to increase shareholder value while advancing products that should improve life for patients with critical or chronic diseases.
Craig Dees, Ph.D., CEO Provectus Pharmaceuticals, Inc. About Provectus Pharmaceuticals, Inc.:
Provectus Pharmaceuticals, Inc. is a pioneering pharmaceutical company actively engaged in the design, development, and marketing of pharmaceutical technologies for the treatment of breast cancer, liver cancer, and metastatic melanoma. In addition, Provectus is preparing to begin Phase 2 clinical studies for the Company’s topical agent Xantryl(TM), a treatment for psoriasis.
The Company’s offices and laboratory are located at 7327 Oak Ridge Highway, Suite A, Knoxville, TN 37931; telephone: 865-769-4011. For more information, contact the Company at info@pvct.com or visit the corporate Web site: http://www.pvct.com .
This release and others statements issued or made from time to time by the company or its representatives contain comments that may constitute forward- looking statements. Those include statements regarding the intent, belief or current expectations of the company and members of its management teams, as well as the assumptions on which the statements are based. Prospective investors are cautioned that such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward- looking statements.
Provectus Pharmaceuticals, Inc.
CONTACT: Peter Culpepper of Provectus Pharmaceuticals, Inc.,+1-865-769-4011, or culpepper@pvct.com; or investors, Matt Clawson of Allen& Caron Inc., +1-949-474-4300, or matt@allencaron.com, for Provectus
Web site: http://www.pvct.com/